Summary of the invention: the objective of the invention is to: a kind of Chinese patent medicine that is used for the treatment of chronic superficial gastritis (gastric abscess) and preparation method thereof is provided.The prescription of this product is that the applicant develops through behind the long-term medical practice; The preparation of selecting for use is the best dosage form of therapeutic effect that recent studies on goes out; In order to prepare these dosage forms, the inventor has also developed relevant preparation method, can directly be used for the production of manufacturing enterprise; The present invention constitutes like this: the Chinese patent medicine preparation of treatment chronic superficial gastritis (gastric abscess), calculate according to components by weight percent: it mainly is prepared from by Radix Codonopsis 90-210 part, Rhizoma Zingiberis 45-105 part, Rhizoma Atractylodis Macrocephalae 90-210 part, Cortex Cinnamomi 45-105 part, Radix Paeoniae Alba 90-210 part, Cortex Magnoliae Officinalis 80-180 part, Fructus Evodiae 45-105 part, Semen Alpiniae Katsumadai 45-105 part, Fructus Litseae 45-105 part, Rhizoma Curcumae 80-180 part, Fructus Aurantii 45-105 part, Fructus Mume 60-140 part, Rhizoma Coptidis 45-105 part, Radix Glycyrrhizae 45-105 part.Best prescription is: it is prepared from by 150 parts of Radix Codonopsis, 75 parts of Rhizoma Zingiberiss, 150 parts of the Rhizoma Atractylodis Macrocephalaes, 75 parts of Cortex Cinnamomis, 150 parts of the Radix Paeoniae Albas, 127.5 parts of Cortex Magnoliae Officinalis, 75 parts of Fructus Evodiaes, 75 parts of Semen Alpiniae Katsumadai, 75 parts of Fructus Litseae, 127.5 parts of Rhizoma Curcumae, 75 parts of Fructus Aurantiis, 97.5 parts of Fructus Mumes, 75 parts of Rhizoma Coptidis, 75 parts in Radix Glycyrrhizae and suitable adjuvant.Used adjuvant can pass through screening according to the difference of preparation dosage form, obtains the most scientific and rational adjuvant.
Be prepared among the present invention capsule can: get the Radix Paeoniae Alba, Rhizoma Coptidis, Fructus Evodiae three flavors and be ground into fine powder, sieve, mixing, standby; Rhizoma Zingiberis, the Rhizoma Atractylodis Macrocephalae (parched with bran), Cortex Cinnamomi, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), Semen Alpiniae Katsumadai, Fructus Litseae, Rhizoma Curcumae, Fructus Aurantii (parched with bran) eight flavors are soaked, distillating extracting oil, filter, divide and get volatile oil, other collects by device respectively for filtrate and medicinal residues, add dehydrated alcohol in the volatile oil, make volatile oil solution, standby; Medicinal residues decoct with water secondary with three flavors such as all the other Radix Codonopsis, Fructus Mume, Radix Glycyrrhizae again, filter, and filtrate and above-mentioned filtrate merge, be condensed into clear paste, spray drying, dry fine powder adds above-mentioned medical material fine powder, mixing, use 70% alcohol granulation, sieve, cold drying, granulate, spray into volatile oil solution, encapsulated, promptly.
Can be like this when the present invention is prepared into tablet: Rhizoma Coptidis powder is broken into fine powder, standby; Get Rhizoma Zingiberis, the Rhizoma Atractylodis Macrocephalae (parched with bran), Cortex Cinnamomi, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens), Semen Alpiniae Katsumadai, Fructus Litseae, Rhizoma Curcumae, Fructus Aurantii (parched with bran) eight flavors and soak, distillating extracting oil filters, and divides and gets volatile oil, and other collects by device respectively for filtrate and medicinal residues, and is standby; The five tastes such as medicinal residues and all the other Radix Codonopsis, the Radix Paeoniae Alba, Fructus Mume, Fructus Evodiae, Radix Glycyrrhizae are decocted with water secondary, filter, filtrate and the merging of above-mentioned filtrate, be condensed into clear paste, spray drying, dry fine powder adds above-mentioned Rhizoma Coptidis fine powder, mixing, use 70% alcohol granulation, drying, granulate, spray into volatile oil, tabletting, the bag film-coat, promptly.
Compared with prior art, medicine preparation provided by the invention has invigorating the spleen and benefiting QI, warming middle-JIAO for easing the stomach, the effect of promoting the circulation of QI to relieve pain, fabulous effect is being arranged and do not having toxic and side effects aspect the treatment of treatment chronic superficial gastritis and spleen-stomach deficiency-cold gastric abscess, preparation method technology provided by the invention is easy, and product quality is convenient to control, directly the suitability for industrialized production of guide product has reached the purpose of inventing.
Gastric abscess motherland medical science is called " syndrome of feeling fullness and distension in the upper abdomen ", " noisy " etc. again, has cold and heat and asthenia and sthenia not, so treatment also has the branch of the clear reinforcing and reducing of temperature.The gastric abscess of syndrome of deficient cold of spleen and stomach is many by innate deficiency, a little less than the middle deficiency of vital energy, and the overstrain impairment of YANG. attack in the suitable exogenous cold, due to the diet raw food, can have that gastral cavilty portion is continuous has a pain, dislike food raw food, diseases such as abdominal distention after meal, its characteristics are vague epigastralgia, and the pain relieved by pressing happiness is warm, and postprandial pain subtracts, thready pulse, heavy empty should the benefit, cold suitable temperature, syndrome of deficient cold of spleen and stomach should be used the method for the warm spleen stomach warming of strong fortune; Pain should lead to, and stagnant should disappearing has gastral cavilty portion stasis distending pain, and belch acid regurgitation person its stasis that then should disappear is led to its QI and blood.
This medicine is with Radix Codonopsis, and Rhizoma Zingiberis QI invigorating warming middle-JIAO is a monarch drug, helps Radix Codonopsis replenishing QI to invigorate the spleen dampness with the Rhizoma Atractylodis Macrocephalae, helps warming middle-JIAO cold expelling stomach warming such as Rhizoma Zingiberis with Cortex Cinnamomi, and with Radix Paeoniae Alba relieving spasm to stop pain yin fluid astringing, Cortex Magnoliae Officinalis promoting the circulation of QI to remove dampness warm in nature removes to expand and is ministerial drug; With Fructus Evodiae, Semen Alpiniae Katsumadai warming spleen and stomach for dispelling cold Shugan Zhitong, Fructus Litseae, Rhizoma Curcumae promoting flow of QI and blood, Fructus Aurantii bitter cold dispelling the stagnated QI removing food stagnancy, Fructus Mume promotes the production of body fluid, and Rhizoma Coptidis expels the heat-evil, and warm drugs such as not only purging liver-fire but also using corrigent Rhizoma Zingiberis, Cortex Cinnamomi are in case the fraud of its scorching impairment of YIN is an adjuvant drug; With Radix Glycyrrhizae invigorating middle warmer stomach function regulating, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription are messenger drug.
In the said medicine, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Radix Glycyrrhizae replenishing QI to invigorate the spleen dampness, warming middle-JIAO cold expelling circulation of qi promoting such as Rhizoma Zingiberis, Cortex Cinnamomi, Fructus Evodiae, Semen Alpiniae Katsumadai can be used as and control Deficiency and coldness of spleen and stomach originally; Fructus Litseae, Rhizoma Curcumae promoting flow of QI and blood; Cortex Magnoliae Officinalis, the Fructus Aurantii therapeutic method to keep the adverse QI flowing downwards are loose full, remove the removing food stagnancy that expands; The Radix Paeoniae Alba, Fructus Mume, Radix Glycyrrhizae sour and sweet drugs can transforme into YIN, yin nourishing easing the affected liver, relieving spasm to stop pain; Again with Rhizoma Coptidis bitter cold purging liver-fire, warm medicine makes it warming spleen and stomach for dispelling cold and non-impairment of YIN is controlled gastral cavilty feeling of fullness distending pain, the mark of belch acid regurgitation in the using corrigent side; Current 12 warps of Radix Glycyrrhizae are with coordinating the actions of various ingredients in a prescription.Radix Codonopsis among the we, the Rhizoma Atractylodis Macrocephalae, Rhizoma Zingiberis, Radix Glycyrrhizae four flavors are ball in the reason, and the spleen invigorating warming middle-JIAO is the representative prescription of treatment Deficiency and coldness of spleen and stomach, and Rhizoma Coptidis, Fructus Evodiae are Zuojin Wan, the merit that the eliminating pathogen in the liver stomach function regulating is arranged, add the Radix Paeoniae Alba and be penta the sixth of the twelve Earthly Branches ball, can fall clearly, can loose and can support, the liver stomach is ruled together, and the effect of relieving spasm to stop pain is arranged.The Radix Paeoniae Alba is closed in the Fructus Mume appetizing of promoting the production of body fluid, and Radix Glycyrrhizaeization the moon, yin nourishing, yin fluid astringing add the product Rhizoma Coptidis of bitter cold, can help anti-its warm-dryness syndrome of system warm drugs and the moon that injures one's stomach; Radix Glycyrrhizae is closed Radix Codonopsis energy replenishing QI to invigorate the spleen, and closing the Radix Paeoniae Alba can relieving spasm to stop pain.Have in all the building up one's health by taking tonic of we to disappear, warming middle-JIAO has clearly, and resolving and invigoration therapies being applied simultaneously is arranged, the effect of simultaneously using both cold and hot drugs.Because warm drugs is on the high side in the side, so the person that is applicable to the Deficiency and coldness of spleen and stomach especially.
Clinical observation test and curative effect
One, case choice criteria:
(1) diagnostic criteria: formulate with reference to " the clinical research guideline of new Chinese medicine treatment chronic superficial gastritis ", " the clinical research guideline of new Chinese medicine treatment gastric abscess ".
(2) tcm symptom classification score standard: formulate with reference to " the clinical research guideline of new Chinese medicine treatment chronic superficial gastritis " and " the clinical research guideline of new Chinese medicine treatment gastric abscess ".
(3) tcm symptom grade scale:
Slightly: tcm symptom integration≤14 minute;
Moderate: tcm symptom integration 14-25 branch;
Severe: tcm symptom integration 〉=25 minute.
(4) include the case standard in:
Meet chronic superficial gastritis Western medicine diagnose standard, and meet Chinese medical discrimination and belong to gastric abscess syndrome of deficient cold of spleen and stomach person, can include the test case in.
Two, test method:
(1) group technology
Random packet is taked in this experiment.To test case by the random code method and be divided into treatment group and matched group at random, wherein 300 examples are organized in treatment, matched group 100 examples.
(2) Therapeutic Method
Treatment group: oral Drug Capsule agent, each 4, every heavily about 0.4g, three times on the one.
(3) course of treatment: 4 weeks were a course of treatment.
Three, observation index:
(1) safety observation
1. general physical examination project;
2. blood, urine, just routine test;
3. the heart, Gan, Kidney functional check;
4. the toxic and side effects of splashing untoward reaction or not expecting.
(2) health giving quality observation
1. clinical symptoms and sign;
2. gastroscopy;
3. biological tissue pathologic finding;
4. helicobacter pylori inspection.
Four, curative effect determinate standard: formulate with reference to " the clinical research guideline of new Chinese medicine treatment chronic superficial gastritis ".
(1) clinical efficacy criterion
1). clinical recovery: symptom, sign disappear; Gastroscope and biopsy, acute inflammation disappears, and chronic inflammatory disease reaches slightly, and bile reflux disappears;
2). produce effects: symptom and sign all improves more than 2 grades; The acutely inflamed main symptom of gastroscope and biopsy disappears substantially, chronic inflammatory disease degree improvement 1 degree, and bile reflux reduces more than 2/3;
3). effectively: symptom and sign all improves more than 1 grade; Gastroscope and biopsy, the mucosa infection scope is dwindled more than 1/2, and the active chronic inflammation degree alleviates 1 degree, and bile reflux reduces more than 1/2;
4). invalid: as not reach effective standard or deterioration person on the contrary.
(2) traditional Chinese medical science symptom curative effect determinate standard
By integration method, judge traditional Chinese medical science symptom curative effect according to therapeutic index.
Recovery from illness: n 〉=90% produce effects: 70%≤n<90%
Effectively: 30%≤n<70% is invalid: n<30%
Five, safety evaluatio standard:
1 grade: safety, do not see any untoward reaction;
2 grades: compare safety,, need not do any processing and can continue administration if any untoward reaction;
3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing;
4 grades: because of test is ended in untoward reaction.
These test of cure group actual observation 314 examples, 16 examples of wherein fully recovering, produce effects 148 examples, effective 117 examples, invalid 49 examples, total effective rate 84.39%, cure-remarkable-effectiveness rate 52.23%.The viewing duration safety indexes is no abnormal, does not see untoward reaction.Result of the test confirms that this medicine is evident in efficacy to chronic superficial gastritis, gastric abscess (spleen-stomach deficiency-cold), drug safety, reliable.
Owing to when the present invention being prepared into the preparation formulation that needs, need select to use different adjuvants and production method; So for the technologies such as adjuvant selection of each dosage form, we have also made experimental selection, as: during with 75%~95% alcohol granulation, fine powder is more in the granule that makes, and the structure pine is dredged, easily fragmentation, and the uniform particles degree is poor; When being lower than 65% alcohol granulation, granule easily bonds, not easy-formation; Through test of many times, it is then suitable with 70% alcohol granulation that we find.
The specific embodiment
Embodiments of the invention 1: Radix Paeoniae Alba 90g, Rhizoma Coptidis 45g, Fructus Evodiae 45g are ground into fine powder, sieve, mixing, standby; Rhizoma Zingiberis 45g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 90g, Cortex Cinnamomi 45g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 80g, Semen Alpiniae Katsumadai 45g, Fructus Litseae 45g, Rhizoma Curcumae 80g, Fructus Aurantii (parched with bran) 45g eight flavors add 5 times of water gagings of water and soak, distillating extracting oil 8 hours, filter, divide and get volatile oil, other collects by device respectively for filtrate and medicinal residues, add the equivalent dehydrated alcohol in the volatile oil, make volatile oil solution, standby; Medicinal residues and Radix Codonopsis 90g, Fructus Mume 60g, Radix Glycyrrhizae 45g add 6 times of water gagings and decoct secondary, and 2 hours for the first time, 1 hour for the second time, filter, filtrate and above-mentioned filtrate merge, and being concentrated into relative density is the clear paste of 1.00~1.20 (80 ℃), spray drying, dry fine powder add above-mentioned medical material fine powder, mixing, use 70% alcohol granulation, cross 30 mesh sieves, cold drying, granulate sprays into volatile oil solution, and sealing is placed, encapsulated, promptly.Oral, 3 times on the one, one time 4.
Embodiments of the invention 2: 105g is ground into fine powder with Rhizoma Coptidis, sieve, and mixing, standby; Rhizoma Zingiberis 105g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 210g, Cortex Cinnamomi 105g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 180g, Semen Alpiniae Katsumadai 105g, Fructus Litseae 105g, Rhizoma Curcumae 180g, Fructus Aurantii (parched with bran) 105g eight flavors add 5 times of water gagings of water and soak, distillating extracting oil 8 hours, filter, divide and get volatile oil, other collects standby by device respectively for filtrate and medicinal residues; Medicinal residues and Radix Codonopsis 210g, Fructus Mume 140g, Radix Glycyrrhizae 105g, Radix Paeoniae Alba 210g, Fructus Evodiae 105g add 6 times of water gagings and decoct secondary, and 2 hours for the first time, 2 hours for the second time, filter, filtrate and above-mentioned filtrate merge, and being concentrated into relative density is the clear paste of 1.05~1.20 (80 ℃), spray drying, dry fine powder adds Rhizoma Coptidis fine powder, mixing, use 70% alcohol granulation, in dry, granulate, spray into volatile oil, tabletting, the bag film-coat, promptly.Oral, 3 times on the one, one time 2.
Embodiments of the invention 3: Radix Paeoniae Alba 150g, Rhizoma Coptidis 75g, Fructus Evodiae 75g are ground into fine powder, sieve, mixing, standby; Rhizoma Zingiberis 75g, the Rhizoma Atractylodis Macrocephalae (parched with bran) 150g, Cortex Cinnamomi 75g, Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 127.5g, Semen Alpiniae Katsumadai 75g, Fructus Litseae 75g, Rhizoma Curcumae 127.5g, Fructus Aurantii (parched with bran) 75 g eight flavors add 5 times of water gagings of water and soak, distillating extracting oil 8 hours, filter, divide and get volatile oil, other collects by device respectively for filtrate and medicinal residues, add the equivalent dehydrated alcohol in the volatile oil, make volatile oil solution, standby; Medicinal residues and Radix Codonopsis 150g, Fructus Mume 97.5g, Radix Glycyrrhizae 75g add 6 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, filter, filtrate and above-mentioned filtrate merge, and being concentrated into relative density is the clear paste of 1.00~1.20 (80 ℃), spray drying, dry fine powder adds above-mentioned medical material fine powder, and mixing is prepared into granule according to conventional method.Oral, 3 times on the one, one time 1 bag.
Other preparation formulation that provides among the present invention prepares if desired, and the applicant found through experiments: can be prepared according to prior art, not need special preparation technology and adjuvant.